Medical System For Annuloplasty

ABSTRACT

A medical system is disclosed for treating a defective mitral valve (MV) having an annulus (A). The system has a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into said CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from the delivery state. The displacement unit has a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to the activated state in which the shape of the annulus is modified to a modified shape (A′); and an annuloplasty device for permanent fixation at the mitral valve annulus by annuloplasty of the valve when the modified shape is obtained.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/891,939 filed Nov. 17, 2015 entitled Medical System For Annuloplasty,which is the U.S. National Phase of and claims priority to InternationalPatent Application No. PCT/EP2014/060434, International Filing Date May21, 2014, entitled Medical System For Annuloplasty, which claims benefitof European Patent Application No. EP13168600.8, filed May 21, 2013entitled Medical System For Annuloplasty, all of which are incorporatedherein by reference in their entireties.

FIELD OF THE INVENTION

This invention pertains in general to the field of annuloplasty devicesfor treating a defective mitral valve. More particularly the inventionrelates to a medical system of devices for treating a defective mitralvalve via coronary sinus and an annuloplasty implant for fixation of theannulus, and a method therefor.

BACKGROUND OF THE INVENTION

Diseased mitral valves frequently need repair to function properly. Themitral valve leaflets or supporting chordae may degenerate and weaken orthe annulus may dilate leading to valve leak (valve insufficiency).Mitral valve repair is frequently performed with aid of an annuloplastyring, used to reduce the diameter of the annulus, or modify the geometryof the annulus in any other way, or aid as a generally supportingstructure during the valve replacement or repair procedure.

Implants have previously been introduced into the coronary sinus (CS) inorder to affect the shape of the valve annulus and thereby the valvefunction. U.S. Pat. No. 6,210,432 and WO02/062270 discloses such implantthat is aimed to replace annuloplasty rings. Permanent implant haveseveral disadvantageous effects, for example since they are implantedinto the CS which is a source for later complications.

Thus, a problem with the prior art implants in the CS is that suchimplants may be less effective in retaining the desired geometry of theannulus. It may be necessary for the implants to be positioned in the CSfor a lengthy time in order to sustain the correct function of thevalve. This pose significant requirements on the long-term function ofthe implant, that may not implants as effective as annuloplasty rings tostart with. A further problem with prior art is thus that complex anddifficult-to-operate devices must be deployed in the CS, that mayrequire frequent adjustment and repositioning to ensure the correctfunction over time. Another problem with prior art devices is thetraumatic effects on the CS itself, due to fixation structures that mustensure the correct position of the device in the CS over time. Anotherproblem is to ensure that a significant part of the annulus is reshapedwhile providing for atraumatic engagement with the anatomy.

EP2072027 discloses a device for insertion into the CS. It is asegmented device that can change its radius. A balloon at the distal endfor providing a temporary fixation point at the distal end is disclosed.

US 2007/185572A1 discloses an implant for treating a mitral valve,comprising an elongate member having a spiral shape, the elongate memberhaving a proximal end portion and a distal end portion, an expandableproximal anchor joined to the proximal end portion of the elongate body,and an expandable distal anchor joined to the distal end portion of theelongate body. The elongate member is configured to adjust from anelongated state to a shortened state after delivery into a coronarysinus for reshaping a mitral annulus.

WO 2004/084746A2 discloses a device for treatment of insufficiency of aheart valve comprising a longitudinal body that can have at least twodifferent forms, namely one easily introduced into the coronary sinus orthe great cardiac vein and to the vessel adaptable form, and a secondone the position of the heart valve affecting form. The second form,when the longitudinal body has been placed into the said vein, pressesthe vessel and thereby the orifice of the heart valve in paralleltowards a closed position.

US 2008/103590A1 discloses a CS device having a coil, which is disposedbetween straight sections and a tether for adjusting the stiffness of aspring and the relative force applied by the device against the adjacenttissue and mitral valve annulus. The mitral valve annulus reshapingdevice includes a distal stent and a proximal stent that are alsopreferably formed of SMA. Distal stent is allowed to expand as itconverts from UM toward its austenitic state once the constraint of thecatheter is removed.

US 2004/153147A1 discloses a method and device for reducing mitralregurgitation. An elongated body is positioned in a coronary sinus of apatient in a vicinity of a heart mitral valve posterior leaflet. Thebody is adapted to straighten a natural curvature of at least a portionof the coronary sinus in the vicinity of the posterior leaflet to move aposterior annulus anteriorly, which in turn moves the posterior leafletanteriorly, thereby to improve leaflet coaptation.

The above problems may have dire consequences for the patient and thehealth care system. Patient risk is increased.

Hence, an improved medical system for performing downsizing andreshaping of the valve annulus would be advantageous and in particularallowing for ensuring long-term functioning, less complex procedure, andless traumatic effects on the anatomy and increased patient safety.

Also, a method of downsizing and reshaping the mitral valve annulus withsuch medical system would be advantageous.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present invention preferably seeks tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device according to the appended patentclaims.

According to a first aspect of the invention a medical system fortreating a defective mitral valve (MV) having an annulus (A) isprovided. The system comprises in combination a removable and flexibleelongate displacement unit for temporary insertion into a coronary sinus(CS) adjacent the valve, wherein the displacement unit has a deliverystate for delivery into said CS, and an activated state to which thedisplacement unit is temporarily and reversibly transferable from thedelivery state. The displacement unit comprises a proximal reversiblyexpandable portion, a distal anchoring portion being movable in relationto the proximal expandable portion in a longitudinal direction of thedisplacement unit to the activated state in which the shape of theannulus is modified to a modified shape (A′); and an annuloplasty devicefor permanent fixation at the mitral valve annulus by annuloplasty ofthe valve when the modified shape is obtained. The annuloplasty devicecomprises a fixation structure that is adapted to retain the modifiedshape. According to a second aspect of the invention a method isprovided for treating a defective mitral valve having an annulus, wherethe method comprises; inserting a flexible and removable elongatedisplacement unit in a delivery state into a coronary sinus (CS)adjacent said valve, positioning a proximal expandable portion against atissue wall at the entrance of said CS, positioning a distal anchoringportion inside said CS, activating said displacement unit in anactivated state whereby said distal anchoring portion is moved in alongitudinal direction of said displacement unit to reduce the distance(L) between said distal anchoring portion and said proximal expandableportion, to a shorter or reduced distance (L′) such that the shape ofthe annulus is modified to a modified shape (A′), fixating anannuloplasty device at the mitral valve annulus when said modified shapeis obtained, whereby said annuloplasty device comprises a fixationstructure that is adapted to retain said modified shape, removing saidelongate displacement unit after temporary activation in the activatedstate.

According to a third aspect of the invention a removable and flexibleelongate displacement unit for temporary insertion into a coronary sinus(CS) adjacent a defective mitral valve (MV) having an annulus (A) isdisclosed. The displacement unit has a delivery state for delivery intosaid CS, and an activated state to which the displacement unit istemporarily and reversibly transferable from said delivery state. Thedisplacement unit comprises a proximal reversibly expandable portion, adistal anchoring portion being movable in relation to said proximalexpandable portion in a longitudinal direction of said displacement unitto said activated state in which the shape of the annulus is modified toa modified shape (A′).

According to a fourth aspect of the invention a medical system fortreating a defective mitral valve having an annulus is provided, wherethe medical system comprises in combination; a removable elongatedisplacement unit for temporary insertion into a coronary sinus (CS)adjacent the mitral valve, wherein the displacement unit has a deliverystate for delivery into the CS, and an activated state to which thedisplacement unit is temporarily and reversibly transferable from thedelivery state, whereby at least a portion of the displacement unit istemporarily movable in a radial direction of the CS towards the valve insuch a manner that the shape of the annulus is modified to a modifiedshape. The medical system further comprising an annuloplasty device forpermanent fixation at the mitral valve annulus by annuloplasty of thevalve when the modified shape is obtained, wherein the annuloplastydevice comprises a fixation structure that is adapted to retain themodified shape.

According to a fifth aspect of the invention a method is provided fortreating a defective mitral valve having an annulus, where the methodcomprises; inserting a removable elongate displacement unit in adelivery state into a coronary sinus (CS) adjacent the mitral valve;activating the displacement unit in an activated state whereby at leasta portion of the displacement unit is moved in a radial direction of theCS towards the valve in such a manner that the shape of the annulus ismodified to a modified shape; fixating an annuloplasty device at themitral valve annulus when then modified shape is obtained, whereby theannuloplasty device comprises a fixation structure that is adapted toretain the modified shape; and removing the elongate displacement unitafter temporary activation in the activated state.

Further embodiments of the invention are defined in the dependentclaims, wherein features for the second and subsequent aspects of theinvention are as for the first aspect mutatis mutandis. In particular,features of the first aspect of the invention as defined in thedependent claims to the first aspect of the invention are also appliedto the third aspect of the invention.

Some embodiments of the invention provide for long-term functioning ofthe mitral valve.

Some embodiments of the invention provide for less complex downsizingprocedures of the mitral valve.

Some embodiments of the invention provide for a reduced risk of damagingthe anatomy such as the CS.

Some embodiments of the invention provide for a secure downsizing whileat the same time reducing the risk of damaging the anatomy such as theCS.

Some embodiments of the invention provide for improved downsizing of themitral valve annulus while ensuring an atraumatic procedure.

Some embodiments of the invention also provide for reduced risk oflong-term negative effects of CS implants.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 is an illustration of the heart showing the coronary sinus inrelation to the mitral valve in a side-view;

FIG. 2a is an illustration of the heart showing the coronary sinus inrelation to a diseased mitral valve in a top-down view;

FIG. 2b is an illustration of a part of a medical system according toembodiments of the invention in a first state;

FIG. 2c is an illustration of a part of a medical system according toembodiments of the invention in a second state;

FIG. 2d is an illustration of a medical system according to embodimentsof the invention;

FIG. 2e is an illustration of a part of a medical system according toembodiments of the invention;

FIG. 2f is an illustration of a part of a medical system according toembodiments of the invention;

FIG. 3a is an illustration of a part of a medical system according toembodiments of the invention in a first state;

FIG. 3b is an illustration of a medical system according to embodimentsof the invention;

FIG. 4a is an illustration of a part of a medical system according toembodiments of the invention in a perspective view;

FIG. 4b is an illustration of a medical system according to embodimentsof the invention in a perspective view;

FIGS. 5a-b are illustrations of a part of a medical system according toembodiments of the invention in a side views;

FIG. 6 is an illustration of a part of a medical system according to anembodiment of the invention in a side view;

FIG. 7 is an illustration of a part of a medical system according to anembodiment of the invention in a side view;

FIGS. 8a-b are illustrations of a part of a medical system according toembodiments of the invention in a side views;

FIGS. 9a-b are illustrations of a part of a medical system according toembodiments of the invention in a top-down view;

FIGS. 10a-b are illustrations of a part of a medical system according toembodiments of the invention in a top-down view;

FIGS. 11a-c are illustrations of a part of a medical system according toembodiments of the invention in a top-down view;

FIG. 12 is a flow chart illustrating a method of treating a defectivemitral valve according to embodiments of the invention;

FIGS. 13a-c are illustrations of a displacement unit according toembodiments of the invention, also being part of a medical systemaccording to embodiments of the invention;

FIGS. 14a-b are illustrations of a displacement unit according toembodiments of the invention, also being part of a medical systemaccording to embodiments of the invention;

FIG. 15 is an illustration of a displacement unit according toembodiments of the invention, also being part of a medical systemaccording to embodiments of the invention;

FIG. 16 is an illustration of a displacement unit according toembodiments of the invention, in use, also being part of a medicalsystem according to embodiments of the invention;

FIG. 17a is an illustration of a displacement unit according toembodiments of the invention, also being part of a medical systemaccording to embodiments of the invention;

FIG. 17b is an illustration of a medical system according to embodimentsof the invention;

FIGS. 18a-b are illustrations of a displacement unit according toembodiments of the invention, also being part of a medical systemaccording to embodiments of the invention;

FIGS. 19a-b are illustrations of a displacement unit according toembodiments of the invention, also being part of a medical systemaccording to embodiments of the invention;

FIG. 20 is a flow chart illustrating a method of treating a defectivemitral valve according to embodiments of the invention.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The following description focuses on an embodiment of the presentinvention applicable to treatment of defective mitral valves byrepairing of the native valve. However, it will be appreciated that theinvention is not limited to this application but may be applied to manyother annuloplasty procedures including for example replacement valves,and other medical implantable devices.

FIG. 1 is an illustration of the heart showing the coronary sinus (CS)in relation to the mitral valve (MV) in a side-view. The CS liesadjacent the MV and follows a curvature around the annulus (A) of theMV, which is further illustrated in the top-down view of FIG. 2 a.

FIG. 2d shows a medical system 100 for treating a defective mitral valve(MV) having an annulus (A) according to an embodiment of the invention.The system comprises in combination a removable elongate displacementunit 101 and a annuloplasty device 102 for permanent fixation at themitral valve. The displacement unit 101 is adapted for temporaryinsertion into the CS adjacent the MV, and it has a delivery state fordelivery into the CS. In the delivery state, the displacement unit 101is bendable in an arch shape at a portion of the displacement unit 101upon said delivery, i.e. as it is positioned in the CS, and cantherefore adapt to the anatomy of the CS and conform to the curvature ofthe CS adjacent a dilated MV, which is illustrated in FIG. 2b . As thedisplacement unit 101 is removable and adapted for temporary insertionin the CS, it may be permanently attached to a delivery unit 111, suchas a delivery wire, guide wire or the like. The displacement unit 101has further an activated state to which the displacement unit istemporarily and reversibly transferable from the delivery state. Thus,at least a portion of the displacement unit 101 is temporarily movablein a radial direction (r) of the CS towards the MV in such a manner thatthe shape of the annulus (A) is modified to a modified shape (A′), asthe displacement unit 101 is transferred its activated state, which isillustrated in FIG. 2c . As the displacement unit is being able to movein the radial direction, efficient downsizing of the valve annulus isprovided. Substantially the entire length of the displacement unit maybe able to move in the radial direction. Alternatively, a portion suchas a middle portion of the displacement unit positionable at the apexpoint 116 of the annulus curve is movable in the radial direction. Thiscan provide for a more efficient and improved downsizing effect thanprior art devices where only the radius of curvature of the device ischanged. The annuloplasty device 102 is adapted for permanent fixationat the mitral valve annulus by annuloplasty of the valve when themodified shape (A′) is obtained. Hence, the annuloplasty device 102comprises a fixation structure 103 that is adapted to retain themodified shape (A′). FIG. 2e shows an example of such annuloplastydevice 102, having a fixation structure in the form of loop structures103 such as a helix-shaped loop structure for positioning on either sideof the MV to retain the modified shape (A′) of the annulus. Theannuloplasty device 102 may be catheter deliverable, whereby it assumesan elongated shape when delivered trough a catheter and transferable toa looped structure when positioned at the MV.

At least a portion of the loop structure 103 conforms to the curvatureof the annulus. In FIG. 2d the annuloplasty device 102 is fixated at theannulus to retain the modified shape of the annulus and provide forclosure of the dilated MV leaflets seen in FIG. 2a . This fixation ofthe previously dilated MV leaflets by the annuloplasty device 102 isaccordingly facilitated and improved by the temporary downsizing of theannulus into the modified shape (A′) by the displacement unit 101, whichis subsequently withdrawn from the CS as illustrated in FIG. 2f . Themedical system 100 therefore provides for efficient permanent fixationof defective MV leaflets via temporary modification or displacement ofthe MV geometry utilizing a removable displacement unit 101 in the CSand an annuloplasty device 102 for fixation of the temporarymodification provided by the displacement unit 101. Since thedisplacement unit 101 is temporarily and reversibly transferable to theactivated state, it may again be reversed to the delivery state, andremoved from the CS. Long term negative effects of implants in the CS orthe need for repositioning or modification of a CS implant to ensureproper long-term function may thereby be avoided. Implants that aretraumatic to the CS, both after short-term or long-term use is alsoavoided. The medical system 100 in combination provides the synergeticeffect of providing efficient temporary downsizing with the displacementunit 101 and fixation of the downsized annulus with the annuloplastydevice 102 in the long-term. Since the displacement unit 101 istemporarily provided in the CS the downsizing can be made in a much morerobust and efficient manner compared to an implant, since the CS is onlyaffected for short period of time while the annuloplasty device 102 isfixated at the annulus. Once the annuloplasty device 102 is fixated thedisplacement unit 101 may be reversed to its delivery state and removedfrom the CS.

Hence, the fixation structure 103 may thus be adapted to retain themodified shape (A′) of the annulus in the delivery state of thedisplacement unit 101 after temporary activation in the activated state.

At least a portion of the displacement unit 101 may be reversiblyexpandable in the radial direction (r) in the activated state. FIG. 2billustrates the delivery state of the displacement unit 101 and FIG. 2cshows the activated state of the latter where the displacement unit 101has been radially expanded to provide the movement in the radialdirection (r) and the temporary downsizing as explained above.

Alternatively, or in addition, at least a portion of the displacementunit 101 may be reversibly foldable in the radial direction (r) in theactivated state. FIG. 3a illustrates the delivery state of thedisplacement unit 101 and FIG. 3b shows the activated state of thelatter where the displacement unit 101 has been folded, curved or bentin the radial direction (r) to provide movement of the annulus in theradial direction (r). This may provide for an improved downsizing as agreater portion of the annulus may be exerted to the force provided bythe displacement unit 101.

At least a portion of the displacement unit may be reversibly movable toan activated shape [in said activated state] that at least partlyassumes the curvature of said loop structure.

The displacement unit 101 may thus have a shape in the activated statethat is customized, adapted, or conformable to the shape of theannuloplasty implant 102. For example, part of the curvature of thedisplacement unit 101 in the activated state may be equal to thecurvature of the loop structure of the annuloplasty implant 102. It isthereby possible to obtain an efficient interplay and synergy betweenthe functions of the displacement unit 101 and the annuloplasty implant102 since the geometries are partly corresponding for an efficientdownsizing into a modified shape of the annulus (A′) that can be fixatedby the annuloplasty implant 102 having a corresponding shape.

The displacement unit may comprise a lumen 105 the in the axialdirection 106 of the displacement unit 101, which is illustrated inFIGS. 4a-b , FIGS. 5a-b , and FIG. 6. It may be desirable improve theblood flow in the CS while the displacement unit 101 is inserted incertain situations, hence the lumen may allow a blood flow therethrough. The lumen 105 may allow insertion of guide wires or the likethrough the displacement unit 101, and further it may allow actuatingunits disposed in the interior of the displacement unit 101 to controlthe shape or size in any parts of the displacement unit 101, to improvethe control of the temporary downsizing procedure.

The displacement unit 101 may comprise at least one inflatable unit 104such as a balloon that is actively and reversibly expandable to a setshape. An inflatable unit 104 provided at a middle portion of thedisplacement unit that is positioned at the apex point 116 of theannulus curve, or having a length corresponding to the portion of the CSextending along annulus of the valve, provides for radial movement alongthis portion, by inflating the balloon. This can provide for a moreefficient and improved downsizing effect than prior art devices whereonly the radius of curvature of the device is changed, or where aballoon is provided at a distal end point for the purpose of anchoringonly. Control of the geometry of the displacement unit 101 is therebyprovided, such that it can be transferred to the activated state in acontrolled manner with a desired geometrical configuration as a setshape, and thereby achieve a desired form of the modified shape (A′) ofthe MV annulus. An arrangement of fluid ports (not shown) may bedisposed in the interior of the displacement unit 101 to its controlinflation in a desired manner. For instance, the inflatable unit 104 mayassume a preset curved shape in the activated state of the displacementunit 101, such that it conforms more to the shape of the annulus. I.e.besides the bendable properties of the displacement unit 101 wheninserted in the CS in the delivery state, it may be actively folded,curved or bent into a shape with a further reduced radius of curvaturewhen transferred into the activated shape, as discussed further below inrelation to FIGS. 9a-b , and FIGS. 11a-c . Further, as seen in FIG. 4bthe displacement unit 101 assumes a curved shape that is bending aroundthe posterior side of the annulus, and as mentioned above, thedisplacement unit 101 may assume a preset curved shape in the activatedstate to further decrease the radius of curvature and improve thedownsizing effect.

The inflatable unit 104 may be asymmetrically expandable in the radialdirection (r) of the CS. The cross-section of such inflatable unit 104is illustrated in FIGS. 5a-b , and FIGS. 8a-b , where the radialportions of the inflatable unit 104 expand to different degrees, henceasymmetrically, in the activated state. For instance, the radial portionof the cross-section to the right in the figures, assumes an increasedcross-section in the activated state (FIG. 5b , FIG. 8b ), whereas theleft portion has not expanded or expanded to a lesser degree, see e.g.left portion 108 compared to right portion 104 in FIG. 8b in theactivated state versus the delivery state (FIG. 8a ). Asymmetricexpansion may improve the downsizing effect in the radial direction (r)of the inflatable unit 104 that is positioned closest to the posteriorside of the annulus, i.e. in the radial direction of the CS. Theasymmetric expansion may be provided by having portions of theinflatable unit 104 of different material properties such as differentexpansion capabilities, or by arranging the inflatable unit 104asymmetrically with respect to a center portion of the displacement unit101. In FIGS. 5a-b a lumen 105 is arranged asymmetrically with respectto such center point 112, i.e. rotational asymmetry, that may providefor a directed expansion of the inflatable unit 104 in a set directionsuch as in the radial direction of the CS.

Reference is now made to FIGS. 9a-b . The inflatable unit 104 may assumea folded or curved shape when expanded in the activated state. Asmentioned this may improve the downsizing further by exerting a forcearound the periphery of the MV at the annulus. In addition, oralternatively to having the inflatable unit 104 to assume a preset shapewhen expanded the displacement unit may comprise a restraining member107 that is arranged to restrict movement of the inflatable unit in atleast one direction when expanded from the delivery state. Therestraining member 107 may accordingly steer the shape of thedisplacement unit 101 even further by limiting expansion or folding incertain directions. For instance, the restraining member 107 may limitexpansion at a first longitudinal side of the inflatable unit 104 sothat during expansion of the inflatable unit 104 in the longitudinaldirection 106, a second side that may be opposite the first side, thatis not restrained, will expand to a larger degree than the first sideand the inflatable unit 104 will fold in the direction of the first sidesince these sides of the inflatable unit 104 will assume differentlengths. FIG. 9b shows folding in this manner, and in the radialdirection of the CS. The restraining member 107 may thus be flexible,and may be affixed to various parts of the displacement unit 101 inorder to achieve the desired shape, such as along a longitudinal side atwith fixation means 113. FIGS. 11a-c shows another example of thedisplacement unit 101 that may assume a folded or curved shape whenexpanded in the activated state by controlling movement of a firstportion of the displacement unit 101 with a restraining member 107, suchthat a second portion moves to a different extent, or along a differentpath, than the first portion.

The at least one inflatable unit 104 may comprise a plurality ofinflatable units wherein a first inflatable unit 104 and a secondinflatable unit 108 are independently and reversibly inflatable. FIG.10a shows a displacement unit 101 that comprises first and secondinflatable units 104, 108, that can be expanded independently and todifferent sizes in the activated state, as seen in FIG. 10b . It isthereby possible to vary the force by which the displacement unit 101exerts on the CS along the length of the displacement unit 101 toachieve a desired modification of the MV annulus and correspondingmodification of the MV leaflets. FIG. 7 and FIGS. 8a-b illustrateembodiments where the displacement unit 101 comprises first and secondinflatable units 104, 108, along the radial direction (r) of thedisplacement unit 101. It may thus be possible to control the amount ofexpansion in the radial direction and achieve asymmetric radialexpansion as discussed above. Further, a passage 114 may be providedalong the axial direction 106 between the first and second inflatableunits 104, 108, as seen in FIG. 7.

FIGS. 11a-c illustrates a displacement unit 101 having first and secondinflatable units 104, 108, along the axial direction 106, and arestraining member 107 at a first portion thereof for controllingmovement in the activated state as explained above in relation to FIGS.9a-b . The displacement unit 101 may assume the shape illustrated inFIG. 11b when in the delivery state and positioned in the CS adjacentthe MV. In this state the first and second inflatable units 104, 108,have been displaced in relation to each other in order to easily conformto the CS anatomy. The first and second inflatable units 104, 108, maybe displaced at their joining ends 115, or in another manner that allowsadapting to the shape of the CS. In FIG. 11c the first and secondinflatable units 104, 108, have assumed an altered shape in theactivated state. Due to the altered shape of each of the inflatableunits 104, 108, they have been displaced in relation to each other at asecond portion of the displacement unit 101, that is not restrained bythe restraining member 107. The displacement unit 101 thereby exhibits afurther modified shape in the activated state as the restraining member107 limits movement of the inflatable units 104, 108, at a portionthereof. This may provide for improving the downsizing effect of the MV.The restraining member 107 may be arranged along a first side of thedisplacement unit 101, attaching and joining each of the first andsecond inflatable units 104, 108, at a first side thereof, and the firstand second inflatable units 104, 108, may each assumed an increasedaxial extension in the activated state such that they are axiallydisplaced at their joining ends 115. Such axial displacement may thus berestricted at the first side due to the fixation of the first and secondinflatable units 104, 108, by the restraining member 107. Unrestrictedaxial expansion at a second side, radially opposite the first side maythus provided for a further folded shape in the activated state.

The displacement unit may comprise, at a radial portion thereof, atleast one radiopaque marker 109, 109′, for rotational alignment of thedisplacement unit in the CS, which is seen in FIG. 4b , and further inFIGS. 5a-b , 6, 7, 8 a-b.

The displacement unit 101 may further comprise a support structure 110arranged to support movement of the displacement unit 101 in the radialdirection (r) and/or support a passageway 105′ through the displacementunit 101 in the axial direction 106, as seen in FIG. 6. The supportstructure may 110 be a framework or a braided structure.

A Method 200 for treating a defective mitral valve (V) having an annulus(A) according to one embodiment of the invention is illustrated in FIG.12. The method comprises inserting 201 a removable elongate displacementunit 101, which may have any combination of the features describedaccording to the disclosure as described above in relation to FIGS.1-11, in a delivery state into a coronary sinus (CS) adjacent the valve;activating 202 the displacement unit 101 in an activated state wherebyat least a portion of the displacement unit 101 is moved in a radialdirection (r) of the CS towards the valve in such a manner that theshape of the annulus is modified to a modified shape (A′); fixating 203an annuloplasty device 102 at the mitral valve annulus when the modifiedshape is obtained, whereby the annuloplasty device 102 comprises afixation structure 103 that is adapted to retain the modified shape; andremoving 204 the elongate displacement unit 101 after temporaryactivation in the activated state.

FIG. 17b show a medical system 300 for treating a defective mitral valve(MV) having an annulus (A). The system 300 comprises in combination aremovable and flexible elongate displacement unit 301 for temporaryinsertion into a coronary sinus (CS) adjacent the valve, wherein thedisplacement unit has a delivery state (FIG. 17a ) for delivery intosaid CS, and an activated state to which the displacement unit istemporarily and reversibly transferable from the delivery state. Thedisplacement unit comprises a proximal reversibly expandable portion302, a distal anchoring portion 303 being movable in relation to theproximal expandable portion in a longitudinal direction 304 of thedisplacement unit (so that the distance (L) between the two portions302, 303, is reduced as seen in FIGS. 18a-b ) to the activated state inwhich the shape of the annulus is modified to a modified shape (A′)(FIG. 17b ); and an annuloplasty device 102 for permanent fixation atthe mitral valve annulus by annuloplasty of the valve when the modifiedshape is obtained (FIG. 17b ). The annuloplasty device 102 comprises afixation structure 103 that is adapted to retain the modified shape. Bymoving the distal anchoring portion 303 in the longitudinal directiontowards the proximal expandable portion 302 the radius of curvature ofthe CS and also the valve annulus can be reduced. The modified shape ofthe annulus is then fixated by the annuloplasty device 102, beforeremoving the displacement unit 101. Previous prior art devices forinsertion into the CS are for permanent implantation and are not adaptedto be removed or used in conjunction with an annuloplasty device 102.Alternatively, the prior art devices are focused bending of a segmenteddevice only. The combination of reducing the length of the displacementunit 301 and having a proximal expandable portion 302 that efficientlyprovides a counter force against the anchoring portion 303, greatlyimproves the downsizing effect. Absence of a proximal expandable portionwill make the downsizing considerably more difficult. The system 300allows for improved efficiency treating diseased valves due to efficientdownsizing of the valve via the CS and subsequent fixation of theannulus at the valve itself. Both the proximal expandable portion 302and the distal anchoring portion 303 are reversibly expandable fordelivery and retrieval from a sheath 310, see FIG. 13c . In oneembodiment the distal anchoring portion 303 and/or the proximalexpandable portion 302 may pivot towards the longitudinal direction 304in order to be easily retracted into the sheath 310, see FIG. 13b .FIGS. 14a-b shows the catheter with the displacement unit 101 at thedistal end to be inserted into the CS. Another embodiment is shown inFIGS. 15 and 16. The distal anchor is inserted and fixated into the CSand the proximal reversibly expandable portion 302 folds out from thesheath 310 to allow for performing the downsizing and is then foldedback into the sheath 310 and is retracted.

The fixation structure 102 is adapted to retain the modified shape ofthe annulus in the delivery state of the displacement unit aftertemporary activation in the activated state.

The distance (L) between the proximal expandable portion 302 and thedistal anchoring portion 303 in the longitudinal direction 304 decreasesto a reduced distance (L′) when the displacement unit 301 is transferredfrom the delivery state to the activated state, see FIGS. 18a-b . Sincethe distal anchoring portion 303 is fixated in the CS decreasing thedistance between the proximal expandable portion 302 and the distalanchoring portion 303 will result in a reduced radius of curvature ofthe CS which will downsize the valve. Thus, the radius of curvature ofthe displacement unit 301 decreases when the displacement unit istransferred from the delivery state to the activated state.

The proximal expandable portion 302 may be reversibly foldable to anexpanded state for positioning against a tissue wall 305 at the entranceof the CS, as shown in FIG. 16. This provides for a very stable fixationof the position of the proximal expandable portion 302 relative thedistal anchor 303 for improved control of the downsizing of the valve.Since the proximal expandable portion 302 may be shaped and adapted forpositioning against the tissue wall 305 at the entrance of the CS, andnot inside the CS itself it also reduces the risk of damaging the CS.Also, since the proximal expandable portion 302 is positioned outsidethe CS it is not constrained by the size of the CS and can thus bereversibly expanded to a diameter that spreads the force over a largerportion, thus reducing the pressure on the tissue. This also reducesrisk of damages.

The proximal expandable portion 302 may comprise expandable wire lobes306, 307, for positioning against the tissue wall 305 at the entrance ofthe CS, see FIG. 15-16. The wires lobes are adapted to be fixatedagainst the tissue wall outside the CS, and provide for a stablefixation point. The wire lobes 306, 307 may expand on either side of thesheath 310 to spread the force symmetrically for controlled positioning.Any expandable structure such as a balloon etc. may be provided asproximal expandable portion 302 for reversible expansion against thetissue wall 305 at the entrance of the CS, i.e. outside the CS toprovide the above mentioned advantages.

The proximal expandable portion 302 may have a larger expanded diameterthan the distal anchoring portion 303 in the activated state of thedisplacement unit 301. This is e.g. illustrated in FIG. 15, and allowsthe proximal expandable portion 302 to be more securely positioned inrelation to the anchor 303 for a more controlled downsizing.

The distal anchoring portion 303 is expandable to anchor against said CSin the activated state of the displacement unit 301. It providessufficient force against the CS to be fixated relative the proximalexpandable portion 302 when pulling the distal anchoring portion 303towards the proximal expandable portion 302.

The distal anchoring portion 303 may comprise an expandable coiled wire311, see FIG. 15. The coiled wire provides for efficient fixationagainst the CS, since pressure is provided evenly and circumferentiallyalong the length of the coil, while at the same times allows to beeasily retracted into the sheath 310 by extending the coil in thelongitudinal direction 304. The coiled wire may be connected to acontrol wire 308, FIG. 15, which is adapted to stretch the distalanchoring portion to a reduced diameter delivery shape, and reducetension on the coiled wire in the activated state to expand the distalanchoring portion. Hence, it also allows for easy deployment of thedistal anchor in the CS by reducing the tension on the coil so that itcan be retracted and expanded in diameter for fixation against the CS.Further, the coil 311 provides for keeping the body lumen open so thatblood flow can be maintained.

The displacement unit 301 may comprise a delivery wire 309, FIGS. 15 and18 a-b, adapted to deliver the distal anchoring portion 303 and to pullthe distal anchoring portion 303 towards the proximal expandable portion302 in the activated state, whereby the distance (L) between the two isreduced to the shorter distance (L′), as illustrated in FIGS. 18a-b , toprovide the downsizing. The control wire 308 for the anchoring portion303 may be pulled simultaneously and with the same displacement so thatthe anchoring portion maintains its length in the longitudinal direction304.

The proximal expandable portion 303 may be reversibly foldable to anexpanded state where the proximal expandable portion 303 has a diametersubstantially larger than the diameter of the CS. This allows for a morestable fixation outside the CS with the advantages mentioned above.

The anchoring portion may comprise a tissue retention portion such as atleast one hook 312, 312′, as illustrated in FIGS. 19a-b . The tissueretention portion 312, 312′, provides for efficient fixation of theanchoring portion 303 inside the CS, that allow for efficient downsizingof the valve annulus. FIG. 19b illustrates the case when to retentionportions 312, 312′, are employed, but any number of retention portionscan be used, to optimize the efficiency of the procedure. In addition tohooks, other retention members grasping the tissue can be provided. Theretention portions 312, 312′, are preferably oriented towards themyocardial wall of the CS which is more robust for grasping of theretention portions 312, 312′.

The anchoring portion 303 may comprise a tissue apposition portion 313having a tissue atraumatic surface, such as an at least partly curved orspherical surface. The tissue apposition portion 313 provides forexerting a counter force against the wall of the CS, stabilizing theanchoring portion 303, and allowing for the retention portion 312, 312′,to more efficiently grasp the tissue and anchor against the same. Also,it helps keeping the CS vein open for sustaining a flow of blood, inaddition to the coil 311 which also keeps the CS vein open. By having atissue atraumatic surface, the tissue apposition portion 313 enhance theanchoring ability while at the same time reducing the risk of tissuedamage to the wall of the CS. FIGS. 19a-b illustrates a sphericalsurface of the apposition portion, but it may have surface that liessmooth against the CS.

The tissue retention portion 312, 312′, is expandable in a directionsubstantially perpendicular to the longitudinal direction 304. It maytherefore efficiently engage the wall of the CS. For example, theretention portion 312, 312′, can be formed of a metal alloy having aheat set shape where it assumes an outwardly curved shape as illustratedin FIGS. 19a-b , for engaging the tissue. The retention portion 312,312′, may be connected to the delivery wire 309, such that when thedelivery wire is pulled back relative the proximal expandable portion302, the retention portion 312, 312′, grasp the tissue, anchors theanchoring portion 303, and draw the tissue against the proximalexpandable portion 302 to achieve the reduced length (L′) and thedownsizing effect. Alternatively, or in addition, the retention portion312, 312′, may be connected to a separate control wire (not shown) sothat the radially outward expansion of the retention portion 312, 312′,can be controlled independently of the position of the delivery wire309. Thus, the retention portion 312, 312′, may first be retracted, e.g.within the coil 311, before pushed in the longitudinal direction 304,where it may assume the heat set radially expanded shape for graspingthe tissue as discussed.

The tissue apposition portion 313 may be controlled and deployed in thesame manner as described in the preceding paragraph for the retentionportion 312, 312′, e.g. being connected to delivery wire 309 or aseparate control wire (not shown), such that the tissue appositionportion can be expandable in a direction substantially perpendicular tothe longitudinal direction 304 for contacting the all of the CS.

The tissue retention portion and said tissue apposition portion may beexpandable in substantially opposite directions, as illustrated in FIGS.19a-b . This allows the tissue apposition portion 313 to provide a goodcounter force relative the retention portion 312, 312′, for efficientgrasping of the tissue and secure anchoring. Also, while the retentionportion 312, 312′, is directed to the stronger myocardial wall, thetissue apposition portion 313 is placed against the more sensitive sideof the CS.

The displacement unit may comprise, at a radial portion thereof, atleast one radiopaque marker 109 for rotational alignment of thedisplacement unit in the CS. E.g. the tissue apposition portion 313 mayhave a radiopaque marker 109 for assisting in orienting away from themyocardial wall. Alternatively, or in addition the retention portion312, 312′, may comprise a radiopaque marker 109.

FIG. 20 illustrates a method 400 for treating a defective mitral valve(V) having an annulus (A) comprising; inserting 401 a flexible andremovable elongate displacement unit 301 in a delivery state into acoronary sinus (CS) adjacent the valve, positioning 402 a proximalexpandable portion 302 against a tissue wall 305 at the entrance of theCS, positioning 403 a distal anchoring portion 303 inside the CS,activating 404 the displacement unit in an activated state whereby thedistal anchoring portion is moved in a longitudinal direction 304 of thedisplacement unit to reduce the distance between the distal anchoringportion and the proximal expandable portion such that the shape of theannulus is modified to a modified shape (A′), fixating 405 anannuloplasty device 102 at the mitral valve annulus when the modifiedshape is obtained, whereby the annuloplasty device comprises a fixationstructure 103 that is adapted to retain the modified shape, removing 406the elongate displacement unit after temporary activation in theactivated state.

The present invention has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the invention. Thedifferent features and steps of the invention may be combined in othercombinations than those described. The scope of the invention is onlylimited by the appended patent claims.

More generally, those skilled in the art will readily appreciate thatall parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the teachings of thepresent invention is/are used.

1-20. (canceled)
 21. Method for treating a defective mitral valve havingan annulus, said method comprising: inserting a flexible and removableelongate displacement unit in a delivery state into a coronary sinusadjacent said valve, positioning a distal anchoring portion inside saidcoronary sinus, positioning a proximal expandable portion against atissue wall outside the entrance of said coronary sinus for providing acounter force against said distal anchoring portion, activating saiddisplacement unit in an activated state whereby said distal anchoringportion is moved in a longitudinal direction of said displacement unitto reduce the distance between said distal anchoring portion and saidproximal expandable portion such that the shape of the annulus ismodified to a modified shape.
 22. Method according to claim 21,comprising fixating an annuloplasty device at the mitral valve annuluswhen said modified shape is obtained, whereby said annuloplasty devicecomprises a fixation structure that is adapted to retain said modifiedshape.
 23. Method according to claim 21, comprising removing saidelongate displacement unit after temporary activation in the activatedstate.
 24. Method according to claim 21, wherein the proximal expandableportion is reversibly foldable to an expanded state from a sheath forpositioning against the tissue wall.
 25. Method according to claim 24,comprising expanding an expandable structure of the proximal expandableportion on either side of the sheath to spread a force symmetricallyagainst a tissue wall outside the entrance of said coronary sinus. 26.Method according to claim 21, comprising pivoting the proximalexpandable portion towards the longitudinal direction.
 27. Methodaccording to claim 24, comprising pivoting first and second expandableportions of the proximal expandable portion in opposite directions ofthe sheath.
 28. Method according to claim 27, comprising pivoting firstand second expandable wires of the proximal expandable portion inopposite directions of the sheath.
 29. Method according to claim 21,comprising decreasing a radius of curvature of the displacement unitwhen the displacement unit is transferred from said delivery state tosaid activated state.
 30. Method according to claim 21, wherein saidproximal expandable portion is foldable to an expanded state where saidproximal expandable portion has a diameter substantially larger than adiameter of said coronary sinus.
 31. Method according to claim 21,wherein said fixation structure comprises a helix-shaped loop structure,the method comprising positioning the helix-shaped loop structure oneither side of said valve to retain said modified shape of the annulusso that at least a portion of the helix-shaped loop structure conformsto a curvature of said annulus.
 32. Method according to claim 31,comprising moving at least a portion of the displacement unit anactivated shape that at least partly assumes the curvature of saidhelix-shaped loop structure.
 33. Method according to claim 21,comprising allowing blood flow through a lumen of the displacement unit,the lumen extending along the longitudinal direction of the displacementunit to improve blood flow through the coronary sinus.
 34. Methodaccording to claim 21, comprising inflating an inflatable unit of thedisplacement unit to exert a force on the coronary sinus.
 35. Methodaccording to claim 21, comprising asymmetrically inflating theinflatable unit of the displacement unit.
 36. Method according to claim34, comprising independently inflating a plurality of inflatable units.